Health Condition 1: null- Obesity
Conditions
Interventions
Dosage form â?? Sachet of 3 gm each Route of Administration â?? Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-Plastic jar containing 30 sachets Duration of th
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. BMI >=30 kg/m2 and 2. Willing and able to participate in the study for 16 weeks.
Exclusion criteria
Exclusion criteria: 1. Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months. 2. Pathophysiologic/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Prader willi syndrome). 3. Patients with evidence of malignancy 4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 6. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 7. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 9. Symptomatic patient with clinical evidence of Heart failure. 10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study. 11. Alcoholics and/or drug abusers. 12. Prior surgical therapy for obesity 13. H/o hypersensitivity to any of the trial drugs or their ingredients. 14. Pregnant / lactating woman. 15. Patients who have completed participation in any other clinical trial during the past six (06) months. 16. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMITimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Lipid ProfileTimepoint: At Baseline and 84th day;Change in quality of life â?? SF-36 ScaleTimepoint: At Baseline, at 84th day and after follow up of 14 weeks;Change in waist circumference and waist: hip ratioTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end offollow up after 14th week | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed